NCT06967181

A Phase 1 Trial of Intranasal Mumps Virus Vaccines in Healthy Adults

A Phase 1 Trial of CVM150 and CVM26 Intranasal Mumps Virus Vaccines in Healthy Adults

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: CyanVac LLC · Industry
• Sex: All
• Age: 18 Years – 29 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to evaluate the safety and immunogenicity of CVM150 and CVM26. The trial will enroll up to 60 healthy participants.

Detailed description

This is a randomized, blinded, placebo-controlled, phase 1 clinical trial to evaluate the safety and immunogenicity of CVM150 and CVM26 in healthy adults who received the recommended 2 doses of mumps vaccine (as measles-mumps-rubella \[MMR\] or MMR -varicella \[MMRV\]) in childhood. Number of Participants: A total of up to 60 participants, aged 18-29 years, are planned to be enrolled. Treatment Assignment: All participants will be randomized to receive a single intranasal dose of CVM150, CVM26 or intranasal saline placebo (1:1:1) on Day 1. Study visits: Participants will be asked to complete approximately 6-8 clinic visits, over a period of approximately 12 months duration per participant.

Conditions

• Mumps

Interventions

Type	Name	Description
BIOLOGICAL	CVM150	CVM150- Live PIV5-based MuV vaccine expressing the MuV (Iowa strain/2006) F and HN proteins formulated in 1x sucrose phosphate glutamate (\[SPG\]; sucrose, KH2PO4, K2HPO4 and L-glutamic acid) buffer.
BIOLOGICAL	CVM26	CVM26: A live, attenuated MuV vaccine based on Iowa strain genetically edited to remove the V and SH protein expression. Formulated in 1x sucrose phosphate glutamate (\[SPG\]; sucrose, KH2PO4, K2HPO4 and L-glutamic acid) buffer.
OTHER	Placebo	Placebo: 0.9% normal sterile saline (purchased commercially).

Timeline

• Start date: 2025-05-14
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-05-13
• Last updated: 2025-12-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study